Car Seat InstallationNCT03508843
Improving Child Restraint Installation
A study testing interactive virtual presence in people with Car Seat Installation, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The investigators will conduct a pre-post trial with 150 parents in rural South Central Montana. The study will recruit families to cooperating community locations (e.g., churches, public libraries) to participate in research evaluating the efficacy of parents installing restraints with guidance from a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Car Seat Installation
- What is being tested?
- interactive virtual presence
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2018to 13 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- communicate in English
- drive a vehicle with one or more car seats present
- willing to install a car seat into the vehicle
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Youth Safety Lab, University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Improving Child Restraint Installation in Rural America Through Interactive Virtual Presence
The investigators will conduct a pre-post trial with 150 parents in rural South Central Montana. The study will recruit families to cooperating community locations (e.g., churches, public libraries) to participate in research evaluating the efficacy of parents installing restraints with guidance from a remotely-located technician using interactive virtual presence. Following informed consent procedures, parents will complete a brief survey on behaviors, attitudes, and perceptions about child safety and restraints while an on-site technician evaluates baseline safety of the restraint. Parents will then engage remotely using their personal smartphone with an off-site certified car seat technician, obtaining advice to install the child restraint properly via the HelpLightning interactive virtual presence app. Following the remote interaction, the on-site technician will again inspect the restraint using the validated checklist (and correct any errors prior to the participant leaving). The overall goal is to demonstrate installation of child restraints can be effectively accomplished to rural populations using interactive virtual presence. The study has 2 specific aims:
Specific Aim 1. Demonstrate technological and behavioral efficacy of providing instructions on child restraint installation remotely to rural populations. Demonstrate >95% of interactions proceed without technical problems, without reports of communication difficulty on either end of the exchange (the parent or the technician), and without interruption.
Specific Aim 2. Identify accuracy of child restraint installation by parents using instructions provided by a remotely-located certified technician via interactive virtual presence. Demonstrate installation in this manner achieves ≥90% accuracy across all aspects of child restraint installation. Demonstrate installation in this manner significantly reduces restraint installation errors.
- Conditions
- Car Seat Installation
- Being tested
- interactive virtual presence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interactive virtual presenceBehavioural
installing the car seat with advice via interactive virtual presence
| Study group | Role | What they receive |
|---|---|---|
| interactive virtual presence | Experimental | install a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence Receives: Behavioral: interactive virtual presence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Accurately Select a Safe Child Restraint
accurate selection of a safe child restraint that was proper for the child's age and size
Measured: immediately (< 5 minutes) after the car seat is installed
Number of Participants Who Install the Child Restraint Accurately Into the Vehicle
accurate installation of the child restraint into the vehicle
Measured: immediately (< 5 minutes) after the car seat is installed
Number of Participants Who Properly Position the Child Restraint in the Vehicle
proper positioning of the child restraint in the vehicle
Measured: immediately (< 5 minutes) after the car seat is installed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2018
- Study start9 Jun 2018
- Primary completion13 Oct 2018
- Study completion13 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Car Seat InstallationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Schwebel, University of Alabama at Birmingham
- Investigators
- David C Schwebel, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03508843
- Sponsor's protocol ID
- 300001220
- Status last verified
- Oct 2019
- First submitted
- 16 Apr 2018
- Last updated
- 18 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Child Restraint Installation in Rural America Through Interactive Virtual Presence
- ClinicalTrials.gov ID
- NCT03508843
- Acronym / sponsor ID
- 300001220
- Conditions
- Car Seat Installation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 9 Jun 2018 (actual)
- Primary completion
- 13 Oct 2018 (actual)
- Study completion
- 13 Oct 2018 (actual)
- First posted
- 26 Apr 2018 (actual)
- Results
- Posted 18 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators will conduct a pre-post trial with 150 parents in rural South Central Montana. The study will recruit families to cooperating community locations (e.g., churches, public libraries) to participate in research evaluating the efficacy of parents installing restraints with guidance from a remotely-located technician using interactive virtual presence. Following informed consent procedures, parents will complete a brief survey on behaviors, attitudes, and perceptions about child safety and restraints while an on-site technician evaluates baseline safety of the restraint. Parents will then engage remotely using their personal smartphone with an off-site certified car seat technician, obtaining advice to install the child restraint properly via the HelpLightning interactive virtual presence app. Following the remote interaction, the on-site technician will again inspect the restraint using the validated checklist (and correct any errors prior to the participant leaving). The overall goal is to demonstrate installation of child restraints can be effectively accomplished to rural populations using interactive virtual presence. The study has 2 specific aims:
Specific Aim 1. Demonstrate technological and behavioral efficacy of providing instructions on child restraint installation remotely to rural populations. Demonstrate >95% of interactions proceed without technical problems, without reports of communication difficulty on either end of the exchange (the parent or the technician), and without interruption.
Specific Aim 2. Identify accuracy of child restraint installation by parents using instructions provided by a remotely-located certified technician via interactive virtual presence. Demonstrate installation in this manner achieves ≥90% accuracy across all aspects of child restraint installation. Demonstrate installation in this manner significantly reduces restraint installation errors.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| interactive virtual presence | Experimental | Behavioral: interactive virtual presenceinstall a car seat using advice from a remotely-located certified car seat technician communicating via interactive virtual presence |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- communicate in English
- drive a vehicle with one or more car seats present
- willing to install a car seat into the vehicle
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interactive virtual presenceinstalling the car seat with advice via interactive virtual presence | Behavioural | interactive virtual presence |
Primary outcome
Number of Participants Who Accurately Select a Safe Child Restraint
Time frame: immediately (< 5 minutes) after the car seat is installed
accurate selection of a safe child restraint that was proper for the child's age and size
Number of Participants Who Install the Child Restraint Accurately Into the Vehicle
Time frame: immediately (< 5 minutes) after the car seat is installed
accurate installation of the child restraint into the vehicle
Number of Participants Who Properly Position the Child Restraint in the Vehicle
Time frame: immediately (< 5 minutes) after the car seat is installed
proper positioning of the child restraint in the vehicle
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David C Schwebel, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interactive virtual presence in people with Car Seat Installation, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Accurately Select a Safe Child Restraint (time frame: immediately (< 5 minutes) after the car seat is installed). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2019.